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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014140
Receipt No. R000016469
Scientific Title Efficacy and Safety of GLP-1 first therapy compared with Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control: a randomized, open-label, multicenter parallel-group study
Date of disclosure of the study information 2014/06/02
Last modified on 2018/12/11

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Basic information
Public title Efficacy and Safety of GLP-1 first therapy compared with Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control: a randomized, open-label, multicenter parallel-group study
Acronym Direct comparison of GLP-1 first therapy and Insulin-GLP-1 relay therapy.
Scientific Title Efficacy and Safety of GLP-1 first therapy compared with Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control: a randomized, open-label, multicenter parallel-group study
Scientific Title:Acronym Direct comparison of GLP-1 first therapy and Insulin-GLP-1 relay therapy.
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm efficacy and safety of GLP-1 first therapy and Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control as introduction of injectable medicine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood glucose control by change in FPG, 1,5-AG and HbA1c.
Achievement rate of HbA1c goals below 7%.
Key secondary outcomes 1 Change in physical findings by change of body weight, adipose mass, basal metabolism and waist circumference
2 Change in biochemical finding
3 Change in lipid metabolism (TC, HDL-C, TG)
Change in hepatic and renal function
4 Identification of predictors for improvement of glucose control
5 Upper limit of daily insulin dose which can be changed from insulin therapy to GLP-1 therapy
6 Adverse events
7 Change in hepatokine

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GLP-1 first therapy
Liraglutide (6 months)
Interventions/Control_2 Insulin GLP-1 relay therapy
Insulin degludec from baseline to 3 month (3 months)
Liraglutide from 4 to 6 month (3 months)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetes with HbA1c above 8%
No limitation in sex and in or out-patients.
Key exclusion criteria Patients who have history of serious hypersensitivity to Liraglutide, Exenatide, Lixisenatide and insulin degludec.
Patients with type 1 diabetes or impaired glucose tolerance due to other specific mechanisms or diseases or gestational diabetes.
Patients with diabetic ketoacidosis
Patients who have history of severe hypoglycemia with coma or loss of consciousness
Patients with serious infection or severe traumatic injury
Patients with steroids as unstable daily dose.
Patients with unstable hypertension with medication like systolic blood pressure above 160 mmHg or diastolic blood pressure above 100mmHg.
Patients with severe hepatic failure or renal failure or cardiac disorder and identified inappropriate patients for this study by the physicians in charge.
Patients with proliferative retinopathy (excluding old proliferative retinopathy without necessary of intervention) and patients with maculopathy with necessary of intervention.
Patients who have history of malignancy
Excluding following patients
Patients who have history of cured basal cell tumor by appropriate treatment or uterocervical carcinoma in situ
Patients who have history of malignancy more than 1 year before and also have no reappearance
Patients who onset malignancy during the period of the study.
Patients with severe complication and identified inappropriate patients for this study by the physicians in charge.
The pregnant women or women having possibilities of being pregnant and the women with breast-feeding
Other patients who are identified inappropriate patients for this study by the physicians in charge.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinari Takamura
Organization Kanazawa university
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
TEL 076-265-2234
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinari Takamura
Organization Kanazawa university
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
TEL 076-265-2234
Homepage URL
Email ttakamura@m-kanazawa.jp

Sponsor
Institute Kanazawa university
Department of Disease Control and Homeostasis
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kanazawa university
Department of Disease Control and Homeostasis
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 02 Day
Last follow-up date
2018 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 02 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016469


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